Sri Satya Sai University of Technology and Medical ...sssutms.co.in/UploadDocument/SYLLABUS/SY_MPH_I.pdf · Sri Satya Sai University of Technology and Medical Sciences, Sehore(M.P.)

Sri Satya Sai University of Technology and Medical Sciences, Sehore(M.P.)

SSSUTMS

Common for all Branch

Subject: ADVANCED ANALYTICAL TECHNIQUES (THEORY) (4 hrs. /week)

Subject code: M PY 101

1. Chromatographic Techniques:

Classification of chromatographic methods based on mechanism of separation and their basic principles.

Gas chromatography: Instrumentation, column efficiency parameters, derivatisation methods,

applications in pharmaceutical analysis.

Liquid chromatography: Instrumentation in HPLC, normal and reversed phase packing materials,

column selection, mobile phase selection, efficiency parameters, applications in pharmaceutical analysis.

Thin Layer Chromatography overview.Instrumentation and applications of HPTLC giving emphasis to use

of TLC- Densitometry in the standardization of some Medicinal Plants. Recent advances in

Chromatography like LCMS, HPTLC MS, LC MS-MS .

2. Spectroscopy:

UV-Visible-Basic principles, Instrumentation, Electronic transitions. Concept of chromophore and

auxochrome, Effect of conjugation, solvent and pH.Instrumentation.Multicomponent analysis. Woodward -

Fieser rules for calculating absorption maximum for unsaturated hydrocarbons. Difference and derivative

spectra.Interpretation of spectra, Qualitative and quantitative analysis of drug molecules.

Infra-Red Spectroscopy: - Basic principle,Interaction of infrared radiation with organic molecules and its

effect on bonds. Instrumentation- Dispersive IR and FT-IR spectrophotometers. Sample preparation &

Sample handling. Interpretation of IR spectra.Fermi Resonance.Brief note on Attenuated Total

Reflectance.Qualitative and quantitative applications of IR.

Nuclear Magnetic Resonance Spectroscopy : - Fundamental principles of NMR.

Instrumentation.Chemical shift concept, spin-spin coupling and decoupling, shielding and deshielding,

solvents.Pascle triangle, signal multiplicity in PMR. Spin-spin and spin- lattice relaxation,

Nuclearoverhauser effect, Interpretation of PMR, C13NMR.

Mass Spectrometry:- Basic principles and instrumentation. Ionization techniques, mass spectrum and its

characteristics, molecular ion, metastable ions, fragment ions; fragmentation processes, fragmentation

patterns and fragment characteristics in relation to parent structure and functional groups. Relative

abundances of isotopes and their contribution to characteristic peaks.


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3. Thermal Methods:

Thermogravimetry, Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC)

4. Immunoassay Techniques:

Enzyme and Radioimmunoassay techniques.Theory, Methods and applications.

5. Quantitative optical spectroscopic method:Theory, instrumentation and applications.

i. Atomic absorption spectroscopic

ii. Inductive coupled plasma atomic emission spectroscopy

iii. Inductive coupled plasma mass spectroscopy

iv. Chemilumience

v. Laser

vi. Photo aquatic spectroscopy

vii. Raman spectroscopy

viii. Optical rotary dispersion

RECOMMENDED BOOKS:

1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6th ed., Baba BarkhaNath Printers, Haryana, 2007.

2. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds.6th ed., John Wiley and Sons (Asia) Pvt. Ltd., Singapore, 2005. 3. William Kemp. Organic Spectroscopy, 3rd ed., Palgrave, New York, 2006

4. Conners KA. Text book of Pharmaceutical analysis, 3rd ed., John Wiley and Sons, Singapore, 2004 5. Willard HH, Merritt LL, Settle FA. Instrumental methods of analysis, 7th ed., CBS Publishers and

Distributors, New Delhi, 1986 6. Sharma BK. Instrumental methods of chemical analysis, 25th ed., Goel Publishing House, Meerut, 2006.

7. Beckett, AH, Stenlake, JB. Practical Pharmaceutical Chemistry, Part I and Part II, 4th ed., CBS Publishers and Distributors, New Delhi, 2004.

8. Ewing, GW. Instrumental methods of chemical analysis, 5th ed., McGraw Hill Book Company, New York, 1985. 9. Houghton P, Mukherjee PK. Evaluation of Herbal Medicinal Product, Pharmaceutical Press, London,

2009. 10. Kalsi, P S. Spectroscopy of Organic Compounds, 2nd ed., Wiley Estern Ltd., Delhi


SSSUTMS

Subject: ADVANCED ANALYTICAL TECHNIQUES (PRACTICAL) (6 hrs. /week)


1. UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlations of

structures and isobestic point in case of mixtures.

2. Estimation of single drug (raw material/ formulation) by colorimetry involving different reagents.

(minimum of 4 experiments)

3. Estimation of single drug (raw material/ formulations) by UV spectrophotometry. (minimum of 4

experiments)

4. Estimation of multicomponent formulation by UV- Spectrophotometer in formulations (minimum of 4

experiments)

5. Effect of pH and solvent on UV Spectrum of certain drugs. (Minimum of 2 experiments)

6. Calibration of IR Spectrophotometer using polystyrene film and checking the performance of the

instrument.

7. Interpretation of structure of drugs by Infra red spectra. (Minimum 4 compounds).

8. Experiments based on the application of derivative spectroscopy. (Minimum of 2 experiments)

9. Standardization and dissolution studies of solid dosage form (Minimum of 5 experiments)

10. Experiments using HPLC: Determination of chromatographic parameters- capacity factor, selectivity,

resolution, efficiency of column HETP, asymmetric factor.

11. Estimation of drugs in biological fluids by HPLC (minimum 2 experiments)

12. Experiments based on application of HPTLC for quantification.


SSSUTMS


Subject: BIOTECHNOLOGY & BIOSTATISTICS (THEORY) (4 Hrs/Week)


1. Genetics: Structure & Function of DNA, DNA Replication &Repair,Expression of Genetic

Information: Structure & Function of RNA,Transcription, Genetic code, Translation, Post translational

modification.

2. Recombinant DNA Technology: Constructing Recombinant DNA molecules Restriction enzymes,

Vectors, Gene Cloning, Genomic libraries,Polymerase Chain reaction – based DNA cloning, Restriction

mapping,

Blotting techniques, DNA sequencing, Pharmaceutical applications of recombinant DNA.

3. Gene Therapy: General Introduction, Potential target diseases for Gene therapy, Gene transfer

methods, Clinical studies, Pharmaceutical production & Regulation.

4. Basics of Immunology, Monoclonal antibodies &Hybridoma technology & its Applications.

Vaccines – Conventional vaccines, Modern Vaccine technologies,Genetically improved live vaccines,

Genetically improved subunit vaccines, Pharmaceutical considerations.

5. BIOSTATISTICS

Probability: Definition of laws of probability, probability distributions, properties of Normal, Binomial,

Poison distributions, sampling distributions of mean and variance, standard error and fiducial limits.

Regression and correlation: Linear and curvilinear regressions, methods of least squares, correlation

coefficients, rank correlation multiple regression.

Tests of significance: Testing hypothesis, errors of two kinds, power of test, test of significance based on

normal distribution and t-test, test for significance of correlation coefficient.

F-test & Analysis of variance: 1-way, 2-way and 3-way classification.

Chi-square test of

(i) Variance of a normal population

(ii) Goodness of fit.

(iii) Independence in contingency tables.


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Statistical quality acceptance of sampling- sampling plans.

REFERENCES:

1. Biostatistics by Alvin E.Lewis.

2. Introduction to probability & Statistics by Henry L.Alder& Edward B. Roessler.

3. Fundamentals of Applied Statistics by S.C.Gupta, V.K.Kapoor

4. Mathematics & Statistics for use in Pharmacy, Biology, Chemistry by Saunders &Flemming.

5. Biotechnology by U.satyanarayna

6. Indian Pharmacopoeia & British Pharmacopoeia. 7. Remington’s Pharmaceutical Sciences.


SSSUTMS

Subject: BIOTECHNOLOGY & BIOSTATISTICS (practical) (4hrs / week)


Isolation of DNA / RNA.

Qualitative & Quantitative analysis of Nucleic acids

Isolation of plasmid DNA.

Restriction Digestion DNA/plasmid

Agarose gel electrophoresis

Southern Blotting, Northern Blotting.

DNA Ligation.


SSSUTMS


Subject: DRUG REGULATORY AFFAIRS (THEORY) (4 hrs. /week)


1. Aims, objects and salient features of following legislations affecting pharmaceutical industry.

a) Industrial Development and Regulation Act 1951.

b) Consumer Protection Act

c) Pollution and Environmental Control Act.

2. Legislation

a. To Regulate the profession of pharmacy – The Pharmacy Act 1948

b. To control the advertisements, excise duties & prices of drug The Drugs and Magic Remedies Act &

Rules (Objectionable advertisements) The Medicinal & Toiletry preparations (The Excise Duties Act-

1955 & Rules 1976).

c. To control the operations relating to dangerous drugs & opium. Narcotic Drugs & Psychotropic

Substance Act 1985.

Standard institutes & certification agencies like ICH, ISO, WHO, USFDA.

3. Intellectual Property Rights Law:

a) Indian Patent Act 1970 and amendments there under,

b) Copyright (Indian) Act

c) Guide lines for filing patents in countries like US & UK.

d) Management of Intellectual Property in Drugs & Pharmaceuticals

e) Good Clinical Practice Guideline, Good Laboratory Practice Guidelines, GMP Guidelines


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f) Drug Regulatory Agencies of the following countries with focus on historical perspectives, organization

structure activities & responsibilities: India, US, Europe and Japan

4. Drug Master File. Preparation of Site Master File, Master Formula Record and DMF Procedure for

filing of Patent.

5. New Drug Application (NDA), Investigational New Drug Application (INDA), Abbreviated New

Drug Application (ANDA). Material Safety Data Sheet (MSDS) preparation and Industrial Safety &

Health

RECOMMENDED BOOKS: -

1. Forensic Pharmacy by B.S. Kuchekar, A. M. Khadatare and S. C. Jitkar, 6th Ed., NiraliPrakashan

2. Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi

3. Mittal B.M., A Textbook of Forensic Pharmacy, 9th Ed., VallabhPrakashan

4. James Swarbrick, James C Boylon, Encyclopedia of Pharmaceutical Technology, 2nd Ed. Marcel

Dekker Inc.

5. Deshpande S.W., Drugs and Cosmetic Act.1940

6. Bubuarm N.R, Whatever one should know about patent, 2nd Ed., Pharma Book Syndicate

7. GMP for pharmaceuticals forth edition by S. Willing, J. Stocker Marcel Decker series 1997.

8. Deshpande S.W, Drug and Magic Remedies Act 1954.

9. P. Warayan, Intellectual Property Laws, Eastern Law House.

10. Drug and Cosmetic Act 1940, Eastern Book company by Vijay Malic, 11th Ed. Patents for Medicine,

by N. B. Zareri, Indian Drug Manufacturers Association (IDMA)

11. Pharmacy Law and Ethics by Dale and Appelbes, The Pharmaceutical Press, Joy Winfield.

12. Guidelines of various countries like MCA, TGA, ICH.


SSSUTMS

For Pharmacology Branch

Subject: PHARMACOLOGY AND TOXICOLOGY THEORY (4 hrs./week)

Subject code: M PC 104

1. Pharmacokinetics:

DRUG ABSORPTION Gastro intestinal, percutaneous and rectal kinetics.Factors affecting drug

absorption.

DRUG DISTRIBUTION :-

a. Plasma Protein binding – factors affecting plasma protein binding.

b. Tissue binding.

c. Transfer of drugs through biological barriers, their therapeutic implication in drug action with

emphasis on drug transporters.

ELIMINATION OF DRUGS:

a. Routes of elimination of drugs.

b. Concept of hepatic and renal clearance.

c. Biological half life.

BIOTRANSFORMATION OF DRUGS :

a. Phase-I and Phase-II metabolic reactions, microsomal and non-microsomal

biotransformation reactions.

b. Drug metabolism in liver, kidney, intestine and factor affecting influencing drug metabolism

2. BIOAVAILABILITY AND BIOEQUIVALENCE OF DRUG PRODUCTS :

Factors affecting bioavailability & importance of bioequivalence studies.

3. PHARMACODYNAMICS :

a. General aspects of receptor pharmacology.

b. Structural and functional aspects of receptors.

c. Regulation of receptors.

d. Classification of receptors.


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4. TOXICOLOGY

a. Principles of toxicology.

b. Abnormal action of drugs such as tolerance, addiction, habituation,idiosyncracy, allergy,

hypersensitivity, antagonism, synergism, potentiation,tachyphylaxis.

c. Adverse drug reactions and its monitoring.

d. Heavy metals poisoning.

5. DRUG INTERACTIONS & RATIONALE FOR DRUG COMBINATIONS:

Its implications and possible means to avoid them. Drug – Drug interactionsinvolving antibiotics,

cardiovascular drugs, antihistaminic drugs and analgesic,anti- inflammatory agents. Various

mechanisms of drug interaction, drug-foodinteraction and drug - drug interaction.


SSSUTMS

Subject: PHARMACOLOGY AND TOXICOLOGY (practical) (6 hrs. /week) Subject code: M PC 104

1. Experiments for studying the effects of the more important biogenic agents likehistamine,

acetylcholine, 5HT, oxytocin and their effect in the presence ofantagonist on suitable isolated

tissue preparations.

2. Estimation of PA2 values of various antagonists under suitable isolated tissuepreparations.

3. Experiments on CVS- Effect of various drugs on isolated heart preparations onvarious animal

models under normal arrhythmic and hypodynamic conditions.

4. Drugs acting on Gastro intestinal tract. To study the drug activity on oesophagalmotility.

5. Monitoring of drug concentration in saliva/urine /blood.

6. Action of CNS stimulants and depressants using suitable experimental model.

7. Evaluation of antidepressant and antianxiety drugs.

8. Drug absorption and elimination studies.

9. Any other experiment based on the topics mentioned in theory.

RECOMMENDED BOOKS:

1. The Pharmacological basis of therapeutics – Goodman and Gilman’s.

2. Pharmacotherapy – DiPiro.

3. Pharmacology – Katzung.

4. Fundamentals of experimental pharmacology by M.N.Ghosh.

5. Handbook of experimental pharmacology by S.K.Kulkarni.

6. Text book of In vitro practical pharmacology by IanKitchen.

7. Pharmacological experiments on intact preparations by Churchill Livingstone.

8. Hand book of clinical pharmacokinetics- Gibaldi and Prescott.

9. Principles of drug action by Goldstein, Amaow and Kalman.

10. Clinical pharmacology by Molmon and Morrelli.

11. Clinical trails and tribulations by Allen E. Cato.

12. Drug interactions by Ivan H. Stockley.

13. Text book of therapeutics- drug, disease and management by Herfindal andGourley.


SSSUTMS

For Pharmaceutics Branch

Subject: PRODUCT DEVELOPMENT AND FORMULATION (THEORY) (4 hrs. /week)

Subject code: M PH 104

1. Preformulation Studies: Timings and goals of Preformulation, Pre-formulation methodology,

solid state properties, partition coefficient, solubility, dissolution, crystal form and stability,

Thermal Analysis, X-ray diffraction:- Techniques to generate & characterize amorphous &

crystalline forms, compatibility tests, dissolution of drug substances and dosage.

2. Kinetic Principles and Stability Testing: Order of reaction, influence of pH, temperature, Acid

- base catalysis. Effect of Ionic strength on degradation, Complex reactions, amide hydrolysis,

Ring alteration, Oxidation - reduction, Ch emical &Physical stability of dosage forms, Influence of

packaging components on dosage form stability. Overages and ICH guidelines.

3. Excipients: Overview of excipients used in formulations. Factors affecting the selection.

Introductory aspects of drug-excipient and excipient, package interaction Study of newer

excipients like cyclodextrin, ion exchange resins, film coating materials, superdisintegrants,

directly compressible vehicles, surfactants- micelle formation, liquid crystal phase, thickeners.

Standardization of excipients.

Polymer Science:- Introduction, classification and methods of preparation of synthetic polymers,

Molecular weight determination , Thermal characterization and rheology of polymers. Introduction

to biodegradable & biodegradable polymers.

4. Diffusion & Dissolution: Concept and importance of dissolution. Steady state diffusion.

Determination of diffusion coefficient & its importance. Concept & importance of dissolution.

Dissolution test, Historical development & USP dissolution test. Dissolution model like Hixson-

Crowell, Higuchi‟s Model. Drug release modeling through polymer matrix & laminates. Concept

of membrane controlled delivery & its importance in dosage form design.

5. Quality Control & Optimization Techniques in Pharmaceutics : Process of dosage forms :

Process control ; Control of quality Validation, Control of manufacturing Process, Statistical

quality control, control charts, sampling plans, Automated & process control, Dosage form control,

Testing programme & method, Product identification systems, Adulteration, Misbranding,

maintenance of records, Bioavailability, Bioequivalence, manufacturer‟s reliability,

Manufacturer/drug information profile. Formulation and Process Optimization parameters,

statistical design, and other application.


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RECOMMENDED BOOKS:

1. Lachmann and Libermann, Theory and Practice of Industrial Pharmacy. Third edition, Varghese

Publishing House.

2. Leon Lachmann, Pharmaceutical dosage forms: Tablets Vol. 1-3. Third Edition, Marcel Deckker.

3. Leon Lachmann. Pharmaceutical Dosage forms: Disperse systems, Vol, 1, 2, 3. Second edition. Marcel

Deckker

4. Gillbert and S. Banker. Modern Pharmaceutics.. Fourth Edition. Volume 121.

5. Remington‟s Pharmaceutical Sciences. Vol.I-II, 21 st Edition.

6. H.S. Bean & A.H. Beckett .Advances in Pharmaceutical Sciences Vol. 1-4.

7. Alfred Martin, Physical Pharmacy. Fifth Edition, Published by B. I. Waverly Pvt. Ltd.

8. Rawlins. Bentley‟s Textbook of Pharmaceutics. Eight Edition

9. Sidney H. Willig. Good manufacturing practices for Pharmaceuticals: A plan for total quality contro l.

Second Ed.

10. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.

11. D.P.S. Kohli and D.H. Shah. Drug formulation manual. Third Edition, Eastern publishers, New Delhi.

12. P. P. Sharma. How to practice GMPs. Fifth Edition, Vandana Publications, Agra.

13. Fra. R. Berry and Robert A. Nash. Pharmaceutical Process Validation. Vol-129, Second Edition.

Revised and Expanded.


SSSUTMS

Subject: PRODUCT DEVELOPMENT AND FORMULATION (Practical) (6hrs. /week)

Subject code: MPH 104

1. Preformulation studies on tablets.

2. To study the decomposition kinetics of any three drugs.

3. To study the effect of copper ions on the ascorbic acid stability in solution

4. To determine the aqueous solubility of given drug sample at various temperature and report its

thermodynamic parameters.

5. To study the dissolution kinetics of given drug.

6. To study the effect of pH (2, 4, 6 and 8.0) on the apparent partition coefficient of a drug in n-octanol-

water buffer system.

7. To study the dissolution kinetics of immediate and extended release dosage form (any five).

8. To study the effect of temperature on rheological behavior of poloxamers.

9. To study the effects of pH on rheological characteristics of carbopol gels using Brookfield viscometer.

10. To determine the best compatible additive for aspirin tablets using at least five known tablet

components.

11. To study the diffusion of drug from topical gel using Franz diffusion cell.

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Sri Satya Sai University of Technology and Medical ...sssutms.co.in/UploadDocument/SYLLABUS/SY_MPH_I.pdf · Sri Satya Sai University of Technology and Medical Sciences, Sehore(M.P.)